Cerevasc announced recently that it has received its second Breakthrough Device designation from the US Food and Drug Administration (FDA) for its investigational eShunt system.
This latest designation pertains to the treatment of communicating hydrocephalus in paediatric patients aged 12 years and older, and was supported by data generated during pilot clinical studies of the device as well as original research published in the Journal of NeuroInterventional Surgery.
The research—conducted at Texas Children’s Hospital (Houston, USA) and Oregon Health and Sciences University (Portland, USA)—retrospectively analysed two cohorts of 50 consecutive patients who underwent high-resolution brain magnetic resonance imaging (MRI).
Measurements of the inferior petrosal sinus (IPS) and cerebellopontine angle cistern (CPAC) were evaluated using established anatomical criteria to assess the feasibility of safe eShunt system implantation. Regression analyses assessed the relationship between patient age and IPS/CPAC measurements.
The results demonstrated that, based on previously established anatomical criteria, endovascular shunt placement was feasible in 67% of the 100 paediatric patients evaluated. There were no statistically significant age-based differences in eligibility (p=0.57), and the majority of patients over one year of age met the IPS and CPAC anatomical criteria for placement of the eShunt system, according to Cerevasc.
“The recognition of Breakthrough Device designation for the eShunt system in paediatric-aged patients demonstrates the profound need for treatment innovation in this patient population, and reinforces the potential safety and efficacy benefits that have already been observed with this minimally invasive, endovascular approach,” said Dan Levangie, chairman and chief executive officer (CEO) of Cerevasc. “We are encouraged and committed to making the eShunt system available to as many patients as possible living with this debilitating disease.”
Cerevasc’s release notes that the present designation will enable priority review and enhanced communication with the US FDA during the clinical trial and regulatory review process for a paediatric indication for the eShunt system.
